cGMP Manufacturing
Overview
For over 40 years Avanti has provided API (Active Pharmaceutical Ingredient) Technology Development for Pharmaceutical and Biotechnology companies. Our unique reputation for quality in the development of pre-clinical and clinical candidates is well established. Our full range of services include process chemistry, scale-up manufacturing, supply chain management with analytical and regulatory requirements. Avanti’s experienced staff of chemists and lipid analysts are ready to meet your development needs with pre-clinical through phase III and commercial launch.
Facility
Avanti Polar Lipids operates FDA inspected and approved facilities, which consist of a total of
80,000 sq/ft in five buildings on our campus, and include:
- Synthetic Organic Laboratories for product development
- Formulation Development and Manufacturing
- cGMP Manufacturing for API production
- cGMP Adjuvant production
- cGMP Analytical Laboratories for product testing and stability studies
Avanti’s facilities and range of services are well suited for lipids and hydrophobic small molecule API Technology Development from pre-clinical through phase III, and API commercial manufacturing for approved drug products.
The Avanti Focus
Avanti will establish a Development Team to ensure the smooth API development you need. Our experienced organic chemists will oversee the process development and scale-up while our lipid analysts guarantee that Avanti quality prevails at each step. A typical development path might include:
- Synthetic process development
- Synthetic scale-up developments (non-cGMP and cGMP)
- Analytical development and validation
- Full scale cGMP manufacturing with process validation
- IND/NDA regulatory support and commercial launch
Products
- Synthetic Phospholipids
- Synthetic Sphingolipids
- Cationic Lipids
- PEG-Lipid Conjugates
- Synthetic Neutral Lipids
- Synthetic Cholesterol
- Synthetic Adjuvants
- Contract Manufacturing of Proprietary Lipid Compounds
- Complete Listing of Avanti's cGMP Lipids: cGMP Manufactured Lipids
cGMP Analytical Services
Avanti is an FDA licensed manufacturing and testing facility. Our Analytical Division along with the support of our Quality Assurance Department can provide the testing you need under strict cGMP compliance. All cGMP services are quoted upon request. Our experienced team of analysts continually incorporate advances in lipid analysis and we have consistently guaranteed the high-purity product that Avanti has provided for almost 50 years.
We can provide:
- Method Design
- Method Development
- Method Qualification
- Method Validation
- Written Standard Operating Procedures
- Fully Documented Sample Receipt/Storage
- Lipid Raw Material Release Testing
- Quality Assurance Review
- Product Release Testing
- Stability Testing
Our most popular cGMP Testing Services include:
cGMP Analytical Method Development, Qualification, and Validation
We perform method design and development for a vast array of assays including NMR, HPLC-ELSD, LC-MS/MS and GC. The goal of method qualification is to demonstrate a method is fit for the intended use. In most instances this requires some demonstration of specificity, accuracy and linearity. As the life cycle of products develop and change we are capable of moving methods from method development through full validation. Method validation requires assessment of clearly defined and agreed upon criteria utilizing a set of assays that demonstrate a robust reproducible method. A protocol is initiated and approved prior to the beginning of validation. The protocol includes experimental design as well as acceptable limits for method performance. The experiments routinely performed in validation include: system suitability, linearity, limit of detection, limit of quantitation, specificity, accuracy, precision (repeatability, reproducibility and intermediate), and robustness (CFR 211.194(a)(2)). We recognize that as the product lifecycle moves forward, and technology constantly changes, validated methods undergo a lifecycle of their own which includes continued method evaluation.
cGMP Stability Testing of Lipid Related Products
Avanti can perform stability testing of lipid-related products or raw materials utilizing a combination of any of our assays. Development of a testing protocol based on ICH Stability Testing Guidelines is available. Samples are sent to Avanti on a pre-determined schedule for analysis. Results are reported back to you upon completion of testing at each time point. Following an initial consultation, we will provide a quotation for stability testing services.
Questions or Ready to get started?
Email our business development team directly at gmp@avantilipids.com
E-mail our analytical team directly at analytical@avantilipids.com